Regeneron Pharmaceuticals announced that the US FDA approved Pasatru (garetosmab-grts) to reduce new heterotopic ossification lesions and flare-ups in adults with fibrodysplasia ossificans progressiva, based on positive Phase 3 OPTIMA trial results. The approval adds a rare-disease monoclonal antibody to Regeneron's portfolio, reinforcing the company's focus on specialized, high-complexity immunology therapies. The Pasatru FOP approval supports the rare-disease angle, but its ultra-rare scope does not materially change the key near term story, which still centers on defending ophthalmology revenues and proving that pipeline investments can support margins as competition and pricing pressures build. The news fits alongside recent ophthalmology updates and the failed non-inferiority readout for EyePoint's Duravyu versus EYLEA in wet AMD, which helps frame the competitive backdrop. Regeneron's narrative projects $19.4 billion revenue and $6.0 billion earnings by 2029, with a fair value estimate of $833.31.
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Regeneron Pharmaceuticals IncFDA approval of Pasatru for FOP based on positive Phase 3 trial results
EyePoint, IncFailed non-inferiority readout for Duravyu versus EYLEA in wet AMD, which helps frame competitive backdrop
